The DAMOCLES Study was commissioned by the NIHR Health Technology Assessment Programme in order to investigate the processes of monitoring accumulating trial data and to identify ways of increasing the likelihood that Data Monitoring Committees (DMCs) make good decisions. The results of the research formed a charter that describes systematically a DMC’s operating practices and procedures.
Data monitoring committee
Most trials have an independent data monitoring committee that follows the progress of the trial and makes sure it is being run properly. The people on the data monitoring committee are experts in clinical trials, statistics or in the disease being studied. They are independent of the researchers running the trial. If they think that participants are experiencing serious or unexpected side effects, or if evidence has emerged that one of the treatments being compared is clearly better than the others, they can advise that a trial is stopped.
Declaration of Helsinki
A statement of ethical principles developed by the World Medical Association to provide guidance to physicians and other participants in medical research involving human subjects.